Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh

Summary

The purpose of this trial is determine whether a 50,000 IU oral dose of vitamin A delivered to newborn infants within the first days of life, reduces six-month infant mortality by at least 15%. The trial will also evaluate whether the survival impact of newborn vitamin A dosing is modified by concurrent weekly, routine maternal vitamin A or beta-carotene supplementation during pregnancy through three months postpartum, gestational age and birth size.

Conditions

• Mortality Through Six Months of Age
• Vitamin A Deficiency

Interventions

DIETARY_SUPPLEMENT

vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)

Single dose of 15,000 ug retinol equivalents at or near birth vs a placebo

Sponsors & Collaborators

• United States Agency for International Development (USAID)

  collaborator FED

• Johns Hopkins University

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Canadian International Development Agency

  collaborator OTHER_GOV

• Access Business Group

  collaborator INDUSTRY

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Rolf DW Klemm, Dr PH · Johns Hopkins University

• Keith P West, Jr., Dr. P.H. · Johns Hopkins Bloomberg School of Public Health

• Parul Christian, Dr. P.H. · Johns Hopkins Bloomberg School of Public Health

• Mahbubar Rashid, MBBS, MSc, MBA · JiVitA Bangladesh Project

• Alain B. Labrique, MSc · Johns Hopkins Bloomberg School of Public Health

• Alfred Sommer, M.D. · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Minute

Max Age

30 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2004-01-31

Primary Completion

2006-12-31

Completion

2006-12-31

Countries

• Bangladesh